Surgical instruments

ABSTRACT

A surgical device. The surgical device may comprise a transducer configured to provide vibrations along a longitudinal axis and an end effector coupled to the transducer and extending from the transducer along the longitudinal axis. The surgical device also may comprise a lower jaw extending parallel to the end effector. The lower jaw may comprise a clamp face extending toward the longitudinal axis. Also, the lower jaw may be slidable relative to the end effector to bring the clamp face toward a distal end of the end effector.

BACKGROUND

Ultrasonic instruments, including both hollow core and solid coreinstruments, are used for the safe and effective treatment of manymedical conditions. Ultrasonic instruments, are advantageous becausethey may be used to cut and/or coagulate organic tissue using energy inthe form of mechanical vibrations transmitted to a surgical end effectorat ultrasonic frequencies. Ultrasonic vibrations, when transmitted toorganic tissue at suitable energy levels and using a suitable endeffector, may be used to cut, dissect, elevate or cauterize tissue or toseparate muscle tissue off bone. Such instruments may be used for openprocedures or minimally invasive procedures, such as endoscopic orlaparoscopic procedures, wherein the end effector is passed through atrocar to reach the surgical site.

Activating or exciting the end effector (e.g., cutting blade) of suchinstruments at ultrasonic frequencies induces longitudinal vibratorymovement that generates localized heat within adjacent tissue,facilitating both cutting and coagulation. Because of the nature ofultrasonic instruments, a particular ultrasonically actuated endeffector may be designed to perform numerous functions, including, forexample, cutting and coagulation.

Ultrasonic vibration is induced in the surgical end effector byelectrically exciting a transducer, for example. The transducer may beconstructed of one or more piezoelectric or magnetostrictive elements inthe instrument hand piece. Vibrations generated by the transducersection are transmitted to the surgical end effector via an ultrasonicwaveguide extending from the transducer section to the surgical endeffector. The waveguides and end effectors are designed to resonate atthe same frequency as the transducer. Therefore, when an end effector isattached to a transducer the overall system frequency is the samefrequency as the transducer itself.

The zero to peak amplitude of the longitudinal ultrasonic vibration atthe tip, d, of the end effector behaves as a simple sinusoid at theresonant frequency as given by:

d=A sin(ωt)

where:ω=the radian frequency which equals 27 c times the cyclic frequency, f;andA=the zero-to-peak amplitude.The longitudinal excursion is defined as the peak-to-peak (p-t-p)amplitude, which is just twice the amplitude of the sine wave or 2A.

Ultrasonic surgical instruments may be divided into two types, singleelement end effector devices and multiple-element end effector devices.Single element end effector devices include instruments such as scalpelsand ball coagulators. Single-element end effector instruments havelimited ability to apply blade-to-tissue pressure when the tissue issoft and loosely supported. Sometimes, substantial pressure may benecessary to effectively couple ultrasonic energy to the tissue. Thisinability to grasp the tissue results in a further inability to fullycoapt tissue surfaces while applying ultrasonic energy, leading toless-than-desired hemostasis and tissue joining. In these cases,multiple-element end effectors may be used. Multiple-element endeffector devices, such as clamping coagulators, include a mechanism topress tissue against an ultrasonic blade that can overcome thesedeficiencies.

Many surgical procedures utilizing harmonic and non-harmonic instrumentscreate extraneous tissue fragments and other materials at the surgicalsite. If this material is not removed, it may obstruct the clinician'sview and also may interfere with the blade or other end effector of thesurgical device. To remove the material, the clinician must remove theinstrument from the surgical area and introduce an aspiration tool. Thiscan break the clinician's concentration and also contribute to physicaland mental fatigue.

Also, in some surgical procedures, it is desirable to remove a core orother integral portion of tissue. In these procedures, the clinicianuses a first instrument to grasp and sometimes cut an outline of thetissue to be removed. Then a second instrument is utilized to remove thetissue from surrounding material, often while the tissue is stillgrasped by the first instrument. This process may be particularlychallenging for clinicians because it can require the use of multipleinstruments, often simultaneously. Also, many coring procedures areperformed at very delicate portions of the anatomy that require precisecuts.

In addition, existing harmonic instruments allow the clinician to turnthem on or off, but provide limited control over the power delivered totissue once the instrument is turned on. This limits the usefulness ofharmonic instruments in delicate surgical procedures, where fine cuttingcontrol is required.

SUMMARY

In one general aspect, the various embodiments are directed to asurgical device. The surgical device may comprise a transducerconfigured to provide vibrations along a longitudinal axis and an endeffector coupled to the transducer and extending from the transduceralong the longitudinal axis. The surgical device also may comprise alower jaw extending parallel to the end effector. The lower jaw maycomprise a clamp face extending toward the longitudinal axis. Also, thelower jaw may be slidable relative to the end effector to bring theclamp face toward a distal end of the end effector.

In another general aspect, the various embodiments are directed toanother surgical device comprising an end effector. The end effector maycomprise a hollow portion defining a central lumen and at least onemember extended across at least a portion of the central lumen at abouta distal end of the end effector.

In yet another general aspect, the various embodiments are directed to asurgical device comprising a central instrument and an outer sheathsurrounding the central instrument. The central instrument may beconfigured to engage tissue, and may be slidable relative to the outersheath. The outer sheath may comprise a distal edge configured to clampthe tissue when the central instrument is slid to a position proximalfrom the distal edge of the outer sheath.

According to still another general aspect, the various embodiments aredirected to a surgical device comprising a transducer configured toenergize an end effector and a trigger actuable to cause the endeffector to be energized. The end effector may be coupled to thetransducer. The surgical device may further comprise a sensor positionedto sense a force exerted on the trigger, and control circuit incommunication with the sensor. The control circuit may be configured toincrease power delivered to the end effector by the transducer inresponse to an increase of the force exerted on the trigger.

FIGURES

The novel features of the various embodiments are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation, together with furtherobjects and advantages thereof, may best be understood by reference tothe following description, taken in conjunction with the accompanyingdrawings as follows.

FIG. 1 illustrates one embodiment of a surgical system including asurgical instrument and an ultrasonic generator;

FIG. 2 illustrates one embodiment of the surgical instrument shown inFIG. 1;

FIG. 3 illustrates an exploded view of one embodiment the surgicalinstrument shown in FIG. 1;

FIG. 4 illustrates one embodiment of a clamping mechanism that may beused with the surgical instrument shown in FIG. 1;

FIG. 5 illustrates a cut-away view of one embodiment of the surgicalinstrument shown in FIG. 1;

FIG. 6 illustrates various internal components of one embodiment of thesurgical instrument shown in FIG. 1;

FIG. 7 illustrates one embodiment of a drive yoke of the surgicalinstrument shown in FIG. 1;

FIG. 8 illustrates one embodiment of a drive collar of the surgicalinstrument shown in FIG. 1;

FIG. 9 illustrates one embodiment of a surgical system including asurgical instrument having single element end effector;

FIG. 10 illustrates one embodiment of a surgical device;

FIGS. 11-12 illustrate exploded views of one embodiment of the surgicaldevice shown in FIG. 10;

FIG. 13 illustrates a side view of one embodiment of the surgical deviceshown in FIG. 10 with the blade and clamp face separated from oneanother;

FIG. 14 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 10 with the blade and clamp face separated from oneanother;

FIG. 15 illustrates a side view of one embodiment of the surgical deviceshown in FIG. 10 with the blade and clamp face translated toward oneanother;

FIG. 16 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 10 with the blade and clamp face translated towardone another;

FIGS. 17-18 illustrate one embodiment of a lower jaw and outer sheath ofthe surgical device shown in FIG. 10;

FIGS. 19-20 illustrate a handle region of one embodiment of the surgicaldevice shown in FIG. 10;

FIG. 20A illustrates one embodiment of the surgical device shown in FIG.10;

FIG. 20B illustrates one embodiment of the surgical device shown in FIG.20A where the end effector is configured to rotate as it moves forwardtoward the clamp face;

FIG. 21 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 10 including a blade defining a hollow lumen;

FIG. 22 illustrates one embodiment of the blade shown in FIG. 21;

FIG. 23 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 10 including a blade defining a hollow lumen andhaving members extending across the hollow lumen;

FIG. 24 illustrates one embodiment of the blade shown in FIG. 23;

FIG. 25 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 10 including a jaw member defining a lumen;

FIG. 26 illustrates one embodiment of a blade for use with the surgicaldevice as shown in FIG. 25;

FIG. 26A illustrates an additional embodiment of the blade of FIG. 26having cutting members positioned within a cavity of the blade.

FIG. 27 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 10;

FIG. 28 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 10 including a plug feature received into a hollowlumen of the end effector;

FIG. 28A illustrates one embodiment of the surgical device of FIG. 10including a rotating end effector;

FIG. 28B illustrates one embodiment of an electric motor for use withthe surgical device of FIG. 28A.

FIG. 28C illustrates one embodiment of the surgical device of FIG. 28Ahaving an angled blade;

FIG. 29 illustrates one embodiment of a hollow core end effectorcomprising members extending across a lumen;

FIG. 30 illustrates one embodiment of a hollow core end effectorcomprising members extending across a lumen;

FIG. 31 illustrates a cut away view of one embodiment of the hollow coreend effector shown in FIG. 30;

FIG. 31A illustrates one embodiment of a hollow core end effector havingangled members;

FIG. 32 illustrates one embodiment of an end effector having anon-integral blade;

FIG. 33 illustrates one embodiment of an end effector having a memberextended across a lumen and edges extending beyond the member;

FIG. 34 illustrates one embodiment of an end effector having aninter-lumen member positioned non-parallel to a longitudinal axis of theend effector;

FIG. 35 illustrates one embodiment of an end effector having amulti-section inter-lumen member;

FIG. 36 illustrates one embodiment of an end effector having inter-lumenmembers extending distally;

FIG. 37 illustrates one embodiment of a surgical device comprising acentral instrument and an outer sheath;

FIG. 38 illustrates one embodiment of the surgical device shown in FIG.37 where the central instrument is grasping tissue;

FIG. 39 illustrates one embodiment of the surgical device shown in FIG.37 where the outer sheath has clamped the tissue;

FIG. 40 illustrates one embodiment of the surgical device shown in FIG.37 where the tissue has been severed;

FIGS. 41-42 illustrate one embodiment of the surgical device shown inFIG. 37 where the outer sheath comprises edge members;

FIGS. 43 and 45 illustrate one embodiment of the outer sheath of thedevice shown in FIG. 37 comprising a pair of jaw members in an openposition;

FIGS. 44 and 46 illustrate one embodiment of the outer sheath of thedevice shown in FIG. 37 where the jaw members are in a closed position;

FIG. 47 illustrates one embodiment of another surgical device having acentral instrument and an outer sheath;

FIG. 48 illustrates one embodiment of the surgical instrument of FIG. 47where the central instrument is extended into tissue;

FIG. 49 illustrates one embodiment of the surgical instrument of FIG. 47where the central instrument has been retracted from the tissue;

FIG. 50 illustrates one embodiment of the surgical instrument of FIG. 47where the outer sheath has been extended into the tissue;

FIG. 51 illustrates one embodiment of the surgical instrument of FIG. 47where the outer sheath has been retracted from the tissue;

FIG. 52 illustrates a block diagram of one embodiment of a surgicaldevice;

FIG. 53 illustrates one embodiment of a surgical device;

FIG. 54 illustrates one embodiment of a surgical device;

FIG. 55 illustrates a distal portion of one embodiment of the surgicaldevice shown in FIG. 54; and

FIG. 56 illustrates one embodiment of a surgical device 700 comprising ahand-piece adapter.

DESCRIPTION

Before explaining the various embodiments in detail, it should be notedthat the embodiments are not limited in application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The illustrative embodiments maybe implemented or incorporated in other embodiments, variations andmodifications, and may be practiced or carried out in various ways. Forexample, the surgical instruments and blade configurations disclosedbelow are illustrative only and not meant to limit the scope orapplication thereof. Also, the blade and end effector designs describedhereinbelow may be used in conjunction with any suitable device.Furthermore, unless otherwise indicated, the terms and expressionsemployed herein have been chosen for the purpose of describing theillustrative embodiments for the convenience of the reader and are notto limit the scope thereof.

Examples of ultrasonic surgical instruments and blades are disclosed inU.S. Pat. Nos. 5,322,055 and 5,954,736, 6,309,400 B2, 6,278,218B1,6,283,981 B1, and 6,325,811 B1, which are incorporated herein byreference in their entirety. These references disclose ultrasonicsurgical instrument designs and blade designs where a longitudinal modeof the blade is excited. The result is a longitudinal standing wavewithin the instrument. Accordingly, the instrument has nodes, where thetransverse motion is equal to zero, and anti-nodes, where the transversemotion is at its maximum. The instrument's tissue end effector is oftenpositioned at an anti-node to maximize its longitudinal motion.

Various embodiments will now be described to provide an overallunderstanding of the principles of the structure, function, manufacture,and use of the devices and methods disclosed herein. One or moreexamples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting embodiments and that the scope ofthe various embodiments is defined solely by the claims. The featuresillustrated or described in connection with one embodiment may becombined with the features of other embodiments. Such modifications andvariations are intended to be included within the scope of the claims.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a surgical device at itshand piece assembly, or other comparable piece. Thus, the end effectoris distal with respect to the more proximal hand piece assembly. It willbe further appreciated that, for convenience and clarity, spatial termssuch as “top” and “bottom” also are used herein with respect to theclinician gripping the hand piece assembly, or comparable piece.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

FIG. 1 illustrates one embodiment of a surgical system including asurgical instrument and an ultrasonic generator. FIG. 2 illustrates oneembodiment of the apparatus shown in FIG. 1. In the embodimentillustrated in FIGS. 1-2, the surgical system 10 includes an ultrasonicclamp coagulator instrument 120 and an ultrasonic generator 30. Thesurgical instrument 120 includes an ultrasonic drive unit 50. As will befurther described, an ultrasonic transducer of the drive unit 50, and anultrasonic end effector 180 of the clamp instrument 120, togetherprovide an acoustic assembly of the surgical system 10, with theacoustic assembly providing ultrasonic energy for surgical procedureswhen powered by generator 30. It will be noted that, in someapplications, the ultrasonic drive unit 50 is referred to as a “handpiece assembly” because the surgical instrument 120 of the surgicalsystem 10 is configured such that a clinician grasps and manipulates theultrasonic drive unit 50 during various procedures and operations. Theinstrument 120 may include a scissors-like grip arrangement whichfacilitates positioning and manipulation of the instrument 120 apartfrom manipulation of the ultrasonic drive unit 50.

The generator 30 of the surgical system 10 sends an electrical signalthrough a cable 32 at a selected excursion, frequency, and phasedetermined by a control system of the generator 30. As will be furtherdescribed, the signal causes one or more piezoelectric elements of theacoustic assembly of the surgical instrument 120 to expand and contractalong a longitudinal axis, thereby converting the electrical energy intomechanical motion. The mechanical motion results in longitudinal wavesof ultrasonic energy that propagate through the acoustic assembly in anacoustic standing wave to vibrate the acoustic assembly at a selectedfrequency and excursion. The end effector 180 is placed in contact withtissue of the patient to transfer the ultrasonic energy to the tissue.For example, a distal portion of blade 180′ of the end effector may beplaced in contact with the tissue. As further described below, asurgical tool, such as, a jaw or clamping mechanism, may be utilized topress the tissue against the blade 180′.

As the end effector 180 couples with the tissue, thermal energy or heatis generated as a result of friction, acoustic absorption, and viscouslosses within the tissue. The heat is sufficient to break proteinhydrogen bonds, causing the highly structured protein (e.g., collagenand muscle protein) to denature (e.g., become less organized). As theproteins are denatured, a sticky coagulum forms to seal or coagulatesmall blood vessels. Deep coagulation of larger blood vessels resultswhen the effect is prolonged.

The transfer of the ultrasonic energy to the tissue causes other effectsincluding mechanical tearing, cutting, cavitation, cell disruption, andemulsification. The amount of cutting as well as the degree ofcoagulation obtained varies with the excursion of the end effector 180,the frequency of vibration, the amount of pressure applied by the user,the sharpness of the end effector 180, and the coupling between the endeffector 180 and the tissue.

In the embodiment illustrated in FIG. 1, the generator 30 includes acontrol system integral with the generator 30, a power switch 34, and atriggering mechanism 36. The power switch 34 controls the electricalpower to the generator 30, and when activated by the triggeringmechanism 36, the generator 30 provides energy to drive the acousticassembly of the surgical system 10 frequency and to drive the endeffector 180 at a predetermined excursion level. The generator 30 drivesor excites the acoustic assembly at any suitable resonant frequency ofthe acoustic assembly.

When the generator 30 is activated via the triggering mechanism 36,electrical energy is continuously applied by the generator 30 to atransducer stack or assembly 40 of the acoustic assembly. A phase-lockedloop in the control system of the generator 30 monitors feedback fromthe acoustic assembly. The phase lock loop adjusts the frequency of theelectrical energy sent by the generator 30 to match the resonantfrequency of the selected longitudinal mode of vibration of the acousticassembly. In addition, a second feedback loop in the control systemmaintains the electrical current supplied to the acoustic assembly at apre-selected constant level in order to achieve substantially constantexcursion at the end effector 180 of the acoustic assembly.

The electrical signal supplied to the acoustic assembly will cause thedistal end of the end effector 180, e.g., the blade 180′, to vibratelongitudinally in the range of, for example, approximately 20 kHz to 250kHz. According to various embodiments, the blade 180′ may vibrate in therange of about 54 kHz to 56 kHz, for example, at about 55.5 kHz. Inother embodiments, the blade 180′ may vibrate at other frequenciesincluding, for example, about 31 kHz or about 80 kHz. The excursion ofthe vibrations at the blade can be controlled by, for example,controlling the amplitude of the electrical signal applied to thetransducer assembly 40 of the acoustic assembly by the generator 30.

As noted above, the triggering mechanism 36 of the generator 30 allows auser to activate the generator 30 so that electrical energy may becontinuously supplied to the acoustic assembly. The triggering mechanism36 may comprise a foot activating switch that is detachably coupled orattached to the generator 30 by a cable or cord. Alternatively, thetriggering mechanism can be configured as a hand switch incorporated inthe ultrasonic drive unit 50 to allow the generator 30 to be activatedby a user.

The generator 30 also has a power line 38 for insertion in anelectro-surgical unit or conventional electrical outlet. It iscontemplated that the generator 30 can also be powered by a directcurrent (DC) source, such as a battery. The generator 30 can compriseany suitable generator, such as Model No. GEN04, available from EthiconEndo-Surgery, Inc.

In the embodiment illustrated in FIGS. 1 and 3, the ultrasonic driveunit 50 of the surgical instrument includes a multi-piece housing 52adapted to isolate the operator from the vibrations of the acousticassembly. The drive unit housing 52 can be shaped to be held by a userin a conventional manner, but it is contemplated that the present clampcoagulator instrument 120 principally be grasped and manipulated by ascissors-like arrangement provided by a housing of the apparatus, aswill be described. While the multi-piece housing 52 is illustrated, thehousing 52 may comprise a single or unitary component.

The housing 52 of the ultrasonic drive unit 50 generally includes aproximal end, a distal end, and a cavity extending longitudinallytherein. The distal end of the housing 52 includes an opening 60configured to allow the acoustic assembly of the surgical system 10 toextend therethrough, and the proximal end of the housing 52 is coupledto the generator 30 by the cable 32. The cable 32 may include ducts orvents 62 to allow air or other fluids to be introduced into the housing52 of the ultrasonic drive unit 50 to cool the transducer assembly 40 ofthe acoustic assembly.

The housing 52 of the ultrasonic drive unit 50 may be constructed from adurable plastic, such as ULTEM®. It is also contemplated that thehousing 52 may alternatively be made from a variety of materialsincluding other plastics (e.g. liquid crystal polymer (LCP), nylon, orpolycarbonate) and/or metals (e.g., aluminum, steel, etc.). A suitableultrasonic drive unit 50 is Model No. HP054, available from EthiconEndo-Surgery, Inc.

The acoustic assembly of the surgical instrument generally includes afirst acoustic portion and a second acoustic portion. The first acousticportion may be carried by the ultrasonic drive unit 50, and the secondacoustic portion (in the form of an end effector 180, as will bedescribed) is carried by the ultrasonic clamp coagulator 120. The distalend of the first acoustic portion is operatively coupled to the proximalend of the second acoustic portion, preferably by a threaded connection.

In the embodiment illustrated in FIG. 2, the first acoustic portionincludes the transducer stack or assembly 40 and a mounting device 84,and the second acoustic portion includes the end effector 180. The endeffector 180 may in turn comprise a transmission component, or waveguide181 (FIG. 3), as well as a distal portion, or blade 180′, forinterfacing with tissue.

The components of the acoustic assembly may be acoustically tuned suchthat the length of each component is an integral number of one-halfwavelengths (nλ/2), where the wavelength λ is the wavelength of apre-selected or operating longitudinal vibration frequency f₀ of theacoustic assembly, and n is any non-negative integer. It is alsocontemplated that the acoustic assembly may incorporate any suitablearrangement of acoustic elements.

The transducer assembly 40 of the acoustic assembly converts theelectrical signal from the generator 30 into mechanical energy thatresults in longitudinal vibratory motion of the end effector 180 atultrasonic frequencies. When the acoustic assembly is energized, avibratory motion standing wave is generated through the acousticassembly. The excursion of the vibratory motion at any point along theacoustic assembly depends on the location along the acoustic assembly atwhich the vibratory motion is measured. A minimum or zero crossing inthe vibratory motion standing wave is generally referred to as a node(e.g., where motion is usually minimal), and a local absolute valuemaximum or peak in the standing wave is generally referred to as ananti-node. The distance between an anti-node and its nearest node isone-quarter wavelength (λ/4).

In the embodiment illustrated in FIG. 2, the transducer assembly 40 ofthe acoustic assembly, which is also known as a “Langevin stack”,generally includes a transduction portion 90, a first resonator 92, anda second resonator 94. The transducer assembly 40 may be an integralnumber of one-half system wavelengths (nλ/2) in length. It is to beunderstood that other embodiments of the transducer assembly 40 maycomprise a magnetostrictive, electromagnetic or electrostatictransducer.

The distal end of the first resonator 92 is connected to the proximalend of transduction section 90, and the proximal end of the secondresonator 94 is connected to the distal end of transduction portion 90.The first and second resonators 92 and 94 may be fabricated fromtitanium, aluminum, steel, or any other suitable material, and mostpreferably, the first resonator 92 is fabricated from 303 stainlesssteel and the second resonator 94 is fabricated from 7075-T651 Aluminum.The first and second resonators 92 and 94 have a length determined by anumber of variables, including the length of the transduction section90, the speed of sound of material used in the resonators 92 and 94, andthe desired fundamental frequency f₀ of the transducer assembly 40. Thesecond resonator 94 can be tapered inwardly from its proximal end to itsdistal end to function as a velocity transformer and amplify theultrasonic vibration excursion.

The transduction portion 90 of the transducer assembly 40 may comprise apiezoelectric section of alternating positive electrodes 96 and negativeelectrodes 98, with the piezoelectric elements 100 alternating betweenthe electrodes 96 and 98. The piezoelectric elements 100 can befabricated from any suitable material, such as, for example, leadzirconate-titanate, lead metaniobate, lead titanate, or otherpiezoelectric material. Each of the positive electrodes 96, negativeelectrodes 98, and piezoelectric elements 100 have a bore extendingthrough the center. The positive and negative electrodes 96 and 98 areelectrically coupled to wires 102 and 104, respectfully. The wires 102and 104 transmit the electrical signal from the generator 30 to theelectrodes 96 and 98.

The piezoelectric elements 100 may be held in compression between thefirst and second resonators 92 and 94 by a bolt 106. The bolt 106 mayhave a head, a shank, and a threaded distal end. The bolt 106 may beinserted from the proximal end of the first resonator 92 through thebores of the first resonator 92, the electrodes 96 and 98, andpiezoelectric elements 100. The threaded distal end of the bolt 106 isscrewed into a threaded bore in the proximal end of second resonator 94.The bolt 106 may be fabricated from steel, titanium, aluminum, or othersuitable material. For example, the bolt 106 may be fabricated fromTi-6A1-4V Titanium or from 4037 low alloy steel.

The piezoelectric elements 100 may be energized in response to theelectrical signal supplied from the generator 30 to produce an acousticstanding wave in the acoustic assembly. The electrical signal causes anelectromagnetic field across the piezoelectric elements 100, causing thepiezoelectric elements 100 to expand and contract in a continuous manneralong the longitudinal axis of the voltage gradient, producing highfrequency longitudinal waves of ultrasonic energy. The ultrasonic energyis transmitted through the acoustic assembly to the end effector 180.

The mounting device 84 of the acoustic assembly has a proximal end, adistal end, and may have a length substantially equal to an integralnumber of one-half system wavelengths (nλ/2). The proximal end of themounting device 84 may be axially aligned and coupled to the distal endof the second resonator 94 by an internal threaded connection near ananti-node. It is also contemplated that the mounting device 84 may beattached to the second resonator 94 by any suitable means, and thesecond resonator 94 and mounting device 84 may be formed as a single orunitary component.

The mounting device 84 is coupled to the housing 52 of the ultrasonicdrive unit 50 near a node. The mounting device 84 may include anintegral mounting flange 108 disposed around its periphery. The mountingflange 108 may be disposed in an annular groove 110 formed in thehousing 52 of the ultrasonic drive unit 50 to couple the mounting device84 to the housing 52. A compliant member or material 112, such as a pairof silicone rubber O-rings attached by stand-offs, may be placed betweenthe annular groove 110 of the housing 52 and the integral flange 108 ofthe mounting device 86 to reduce or prevent ultrasonic vibration frombeing transmitted from the mounting device 84 to the housing 52.

The mounting device 84 may be secured in a predetermined axial positionby a plurality of pins 114, for example, four. The pins 114 are disposedin a longitudinal direction ninety (90) degrees apart from each otheraround the outer periphery of the mounting device 84. The pins 114 arecoupled to the housing 52 of the ultrasonic drive unit 50 and aredisposed through notches in the acoustic mounting flange 108 of themounting device 84. The pins 114 may be fabricated from stainless steel.According to various embodiments, the pins 114 may be formed as integralcomponents of the housing 52.

The mounting device 84 may be configured to amplify the ultrasonicvibration excursion that is transmitted through the acoustic assembly tothe distal end of the end effector 180. In one embodiment, the mountingdevice 84 comprises a solid, tapered horn. As ultrasonic energy istransmitted through the mounting device 84, the velocity of the acousticwave transmitted through the mounting device 84 is amplified. It iscontemplated that the mounting device 84 be configured as any suitableshape, such as, for example, a stepped horn, a conical horn, anexponential horn, a unitary gain horn, or the like.

The mounting device 84 may be acoustically coupled to the secondacoustic portion of the ultrasonic clamp coagulator instrument 120. Thedistal end of the mounting device 84 may be coupled to the proximal endof the second acoustic portion by an internal threaded connection nearan anti-node, but alternative coupling arrangements can be employed.

FIG. 3 illustrates an exploded view of one embodiment the surgicalinstrument shown in FIG. 1. The proximal end of the ultrasonic clampcoagulator instrument 120 preferably receives and is fitted to thedistal end of the ultrasonic drive unit 50 by insertion of the driveunit 50 into the housing 52, as shown in FIG. 2. The ultrasonic clampcoagulator instrument 120 may be attached to and removed from theultrasonic drive unit 50 as a unit. The ultrasonic clamp coagulator 120may be disposed of after a single use.

The ultrasonic clamp coagulator instrument 120 may include a handleassembly or a housing 130, which may comprise mating housing portions131, 132, and an elongated or endoscopic portion 150. When the presentapparatus is configured for endoscopic use, the construction can bedimensioned such that portion 150 has an outside diameter of about 5.5mm. The elongated portion 150 of the ultrasonic clamp coagulatorinstrument 120 may extend substantially orthogonally from the apparatushousing 130. The elongated portion 150 can be selectively rotated withrespect to the housing 130 as described below. The elongated portion 150may include an outer tubular member or sheath 160, an inner tubularactuating member 170, and the second acoustic portion of the acousticsystem in the form of an end effector 180 including a blade 180′. Aswill be described, the outer sheath 160, the actuating member 170, andthe end effector 180 may be joined together for indexed rotation as aunit (together with ultrasonic drive unit 50) relative to housing 130.

The proximal end of the end effector 180 of the second acoustic portionmay be detachably coupled to the mounting device 84 of the ultrasonicdrive unit 50 near an anti-node as described above. The end effector 180may have a length substantially equal to an integer number of one-halfsystem wavelengths (nλ/2). The end effector 180 may be fabricated from asolid core shaft constructed out of material which propagates ultrasonicenergy efficiently, such as a titanium alloy (e.g., Ti-6A1-4V) or analuminum alloy. It is contemplated that the end effector 180 canalternatively be fabricated from any other suitable material.

As described, the end effector 180 may include a waveguide 181. Thewaveguide 181 may be substantially semi-flexible. It will be recognizedthat the waveguide 181 can alternatively be substantially rigid or maycomprise a flexible wire. The waveguide 181 may be configured to amplifythe mechanical vibrations transmitted through the waveguide to the bladeas is well known in the art. The waveguide 181 may further have featuresto control the gain of the longitudinal vibration along the waveguide181 and features to tune the waveguide to the resonant frequency of thesystem.

It will be recognized that the end effector 180 may have any suitablecross-sectional dimension. For example, the end effector 180 may have asubstantially uniform cross-section or the end effector 180 may betapered at various sections or may be tapered along its entire length.

Referring now to FIG. 3, the waveguide 181 portion of the end effector180 is shown to comprise a first section 182, a second section 184, anda third section 186. The first section 182 of may extend distally fromthe proximal end of the end effector 180, and has a substantiallycontinuous cross-section dimension. The first section 182 may include atleast one radial hole or aperture 188 extending diametricallytherethrough, substantially perpendicular to the axis of the endeffector 180. The aperture 188 may be positioned at a node, but may beotherwise positioned. It will be recognized that the aperture 188 mayhave any suitable depth and may be any suitable shape. The aperture 188is configured to receive a connector pin member which connects the waveguide 181, the tubular actuating member 170, and the tubular outersheath 160 together for conjoint, indexed rotation relative to apparatushousing 130.

The second section 184 of the wave guide 181 extends distally from thefirst section 182. The second section 184 preferably also has asubstantially continuous cross-section. The diameter of the secondsection 184 may be smaller than the diameter of the first section 182and larger than the diameter of the third section 186. As ultrasonicenergy passes from the first section 182 of the end effector 180 intothe second section 184, narrowing of the second section 184 will resultin an increased amplitude of the ultrasonic energy passing therethrough.

The third section 186 extends distally from the distal end of the secondsection 184. The third section 186 also has a substantially continuouscross-section. The third section 186 also may include small diameterchanges along its length. According to various embodiments, thetransition from the second section 184 to the third section 186 may bepositioned at an anti-node so that the diameter change in the thirdsection does not bring about an increase in the amplitude of vibration.

The third section 186 may have a plurality of grooves or notches (notshown) formed in its outer circumference. The grooves may be located atnodes of the end effector 180 to act as alignment indicators for theinstallation of a damping sheath (not shown) and stabilizing siliconerings or compliant supports during manufacturing. A seal may be providedat the distal-most node, nearest the blade 180′, to abate passage oftissue, blood, and other material in the region between the waveguideand actuating member 170.

The blade 180′ of the end effector 180 may be integral therewith andformed as a single unit. The blade 180′ may alternately be connected bya threaded connection, or by a welded joint. According to variousembodiments, the blade 180′ may be mechanically sharp or mechanicallyblunt. The distal end of the blade 180′ is disposed near an anti-node inorder to tune the acoustic assembly to a preferred resonant frequency f₀when the acoustic assembly is not loaded by tissue. When the transducerassembly is energized, the distal end of the blade 180′ is configured tomove longitudinally in the range of, for example, approximately 10-500microns peak-to-peak, and preferably in the range of about 10 to about100 microns at a predetermined vibrational frequency f₀.

In accordance with the illustrated embodiment, the blade 180′ may becylindrical for cooperation with the associated clamping mechanism ofthe clamp coagulator 120. The end effector 180 may receive suitablesurface treatment, as is known in the art.

FIG. 4 illustrates one embodiment of a clamping mechanism that may beused with the surgical instrument shown in FIG. 1. The clampingmechanism may be configured for cooperative action with the blade 180′of the end effector 180. The clamping mechanism includes a pivotallymovable clamp arm 190, which is pivotally connected at the distal endthereof to the distal end of outer tubular sheath 160. The clamp arm 190includes a clamp arm tissue pad 192, preferably formed from TEFLON® orother suitable low-friction material, which is mounted for cooperationwith the blade 180′, with pivotal movement of the clamp arm 190positioning the clamp pad 192 in substantially parallel relationship to,and in contact with, the blade 180′. By this construction, tissue to beclamped is grasped between the tissue pad 192 and the blade 180′. Thetissue pad 192 may be provided with a sawtooth-like configurationincluding a plurality of axially spaced, proximally extending grippingteeth 197 to enhance the gripping of tissue in cooperation with theblade 180′.

Pivotal movement of the clamp arm 190 with respect to the blade 180′ iseffected by the provision of at least one, and preferably a pair oflever portions 193 of the clamp arm 190 at the proximal end thereof. Thelever portions 193 are positioned on respective opposite sides of theend effector 180 and blade 180′, and are in operative engagement with adrive portion 194 of the reciprocal actuating member 170. Reciprocalmovement of the actuating member 170, relative to the outer tubularsheath 160 and the end effector 180, thereby effects pivotal movement ofthe clamp arm 190 relative to the blade 180′. The lever portions 193 canbe respectively positioned in a pair of openings defined by the driveportion 194, or otherwise suitably mechanically coupled therewith,whereby reciprocal movement of the actuating member 170 acts through thedrive portion 194 and lever portions 193 to pivot the clamp arm 190.

FIG. 5 illustrates a cut-away view of one embodiment of the surgicalinstrument shown in FIG. 1, while FIG. 6 illustrates various internalcomponents of one embodiment of the surgical instrument shown in FIG. 1.FIG. 7 illustrates one embodiment of a drive yoke, and FIG. 8illustrates one embodiment of a drive collar of the surgical instrumentshown in FIG. 1. In the embodiment illustrated in FIGS. 3 and 5-8,reciprocal movement of the actuating member 170 is effected by theprovision of a drive collar 200 mounted on the proximal end of theactuating member 170 for conjoint rotation. The drive collar 200 mayinclude a pair of diametrically opposed axially extending arms 202 eachhaving a drive lug 204, with the drive lugs 204 being biased by the arms202 into engagement with suitable openings 206 defined by the proximalportion of tubular actuating member 170. Rotation of the drive collar200 together with the actuating member 170 is further effected by theprovision of a pair of keys 208 diametrically engageable with suitableopenings 210 defined by the proximal end of the actuating member 170. Acircumferential groove 211 on the actuating member 170 receives anO-ring 211′ (FIG. 3) for engagement with the inside surface of outersheath 160.

Rotation of the actuating member 170 together with the tubular outersheath 160 and inner end effector 180 is provided by a connector pin 212extending through these components of the instrument 120. The tubularactuating member 170 defines an elongated slot 214 through which theconnector pin 212 extends to accommodate reciprocal movement of theactuating member relative to the outer tubular sheath and innerwaveguide.

A rotation knob 216 mounted on the outer tubular sheath facilitatesrotational positioning of the elongated portion 150 with respect to thehousing 130 of the clamp coagulator instrument 120. Connector pin 212preferably joins the knob 216 together with the sheath 160, member 170,and the end effector 180 for rotation as a unit relative to the housing130. In the embodiment, hub portion 216′ of the rotation knob 216 actsto rotatably mount the outer sheath 160, the actuating member 170, andthe end effector 180 (as a unit with the knob 216), on the housing 130.

The drive collar 200 provides a portion of the clamp drive mechanism ofthe instrument 120, which effects pivotal movement of the clamp arm 190by reciprocation of the actuating member 170. The clamp drive mechanismfurther includes a drive yoke 220 which is operatively connected with anoperating lever 222, with the operating lever thus interconnected withthe reciprocal actuating member 170 via drive yoke 220 and drive collar200. The operating lever 222 is pivotally connected to the housing 130of the apparatus (by a pivot mount 223) for cooperation in ascissors-like fashion with a handgrip portion 224 of the housing.Movement of the lever 222 toward the handgrip portion 224 translates theactuating member 170 proximally, thereby pivoting the clamp arm 190toward the blade 180′.

Operative connection of the drive yoke 220 with the operating lever 222is provided by a spring 226, preferably comprising a compression coilspring 226. The spring 226 fits within a spring slot 228 defined by thedrive yoke 220, which in turn is positioned between a pair of springretainer flanges 230 of the operating lever 222. The drive yoke 220 ispivotally movable with respect to the spring flanges 230 (about pivotmount 223 of housing 130) in opposition to the compression coil spring,which bears against the surfaces of the spring slots defined by each ofthe spring flanges 230. In this manner, the force which can be appliedto the actuating member 170, by pivotal movement of the operating lever222 acting through the drive yoke 220 and the drive collar 200, islimited by the force with which the spring 226 bears against the springflanges 230. Application of excessive force results in pivotaldisplacement of the drive yoke 220 relative to the spring flanges 230 ofthe operating lever 222 in opposition to spring 226. Stop portions ofthe housing 130 limit the travel of the operating lever 222 to preventexcessive compression of spring 226. In various embodiments, the forceapplied to the actuating member 170 may be limited by one or moresprings (not shown) operatively positioned between the drive collar 200and the member 170. For example, one or more cylindrical springs, suchas a wave springs, may be used. An example embodiment utilizing a wavespring in this manner is described in U.S. Pat. No. 6,458,142, which isincorporated herein by reference.

Indexed rotational positioning of the elongated portion 150 of thepresent clamp coagulator instrument 120 may be provided by the provisionof a detent mechanism incorporated into the clamp drive mechanism of theinstrument 120. Specifically, the drive collar 200 may include a pair ofaxially spaced apart drive flanges 232. A detent-receiving surface maybe provided between the drive flanges 232, and may define a plurality ofcircumferentially spaced teeth 234. The teeth 234 may definedetent-receiving depressions generally about the periphery of the drivecollar 200. In the embodiment illustrated in FIG. 7, twelve (12) of theteeth 234 are provided, thereby providing indexed positioning of theelongated portion 150 of the apparatus at 30° intervals relative to thehousing 130 of the apparatus.

Indexed rotational movement may be further achieved by the provision ofat least one, and preferably a pair, of diametrically opposed detents236 respectively provided on cantilevered yoke arms 238 of the driveyoke 220. By this arrangement, the yoke arms 238 are positioned betweenthe drive flanges 232 for engagement with the confronting surfacesthereof, and bias the detents 236 into engagement with the drive collar200. Indexed relative rotation is thus achieved, with the detents 236 ofthe yoke arms 238 cooperating with the drive flanges 238 for effectingreciprocation of the actuating member 170. According to variousembodiments, the drive yoke 220 may be formed from suitable polymericmaterial, with the biasing force created by the yoke arms 238 acting onthe detents 236 thereof cooperating with the radial depressions definedby the drive collar to resist relative rotational torque less than about5 to 20 inch-ounces. Accordingly, the elongated portion 150 of the clampcoagulator instrument 120 is maintained in any of its selected indexedrotational positions, relative to the housing 130, unless a torque isapplied (such as by the rotation knob 216) exceeding this predeterminedtorque level. A snap-like indexing action is thus provided.

Rotation of the elongated proportion 150 of the present clamp coagulatorinstrument 120 may be effected together with relative rotationalmovement of ultrasonic drive unit 50 with respect to housing 130. Inorder to join the elongated portion 150 to the ultrasonic drive unit 50in ultrasonic-transmitting relationship, the proximal portion of theouter tubular sheath 160 may be provided with a pair of wrench flats 240(FIG. 3). The wrench flats allow torque to be applied by a suitabletorque wrench or the like to thereby permit the end effector 180 to bejoined to the ultrasonic drive unit 50. The ultrasonic drive unit 50, aswell as the elongated portion 150, are thus rotatable, as a unit, bysuitable manipulation of the rotation knob 216, relative to the housing130 of the apparatus. The interior of housing 130 is dimensioned toaccommodate such relative rotation of the drive unit 50.

FIG. 9 illustrates one embodiment of a surgical system 250 including asurgical instrument 251 having single element end effector 256. Thesystem 250 may include a transducer assembly 252 coupled to the endeffector 256 and a sheath 254 positioned around the proximal portions ofthe end effector 256 as shown. The transducer assembly 252 and endeffector 256 may operate in a manner similar to that of the transducerassembly 50 and end effector 180 described above to produce ultrasonicenergy that may be transmitted to tissue via blade 256′

FIG. 10 illustrates one embodiment of a surgical device 300. FIGS. 11-12illustrate exploded views of one embodiment of the surgical device 300shown in FIG. 10. Generally, the surgical instrument 300 may comprise atransducer assembly 302, an end effector 304 and a lower jaw 306. Theend effector 304 may be at least partially enclosed by a sheath 314. Thelower jaw 306 may include a clamp face 308, and may be slidable relativeto the end effector to bring the clamp face 308 toward a distal end ofthe end effector 304. According to various embodiments, the end effector304 and/or the lower jaw 306 may define a lumen for aspirating asurgical site. Also, various blades 304′ may be included with the endeffector 304, for example, to bring about different surgical results.

FIGS. 13-14 illustrate one embodiment of the surgical device 300 shownin FIG. 10 configured in an open position with the blade 304′ and clamp308 separated from one another. In use, a clinician may introduce thedevice 300 to a surgical site the open position illustrated in FIGS.13-14. When the device 300 is properly positioned, the clinician maytransition the device 300 to a closed position, for example, byactuating a trigger 310. FIGS. 15-16 illustrate one embodiment of thesurgical device 300 shown in FIG. 10 configured in a closed positionwith the blade 304′ and clamp 308 translated towards one another. In theembodiment shown in FIGS. 15-16, the trigger has been rotated towards ahandle 312, causing the lower jaw 306 to translate relative to the endeffector 304, and bringing the clamp face 308 towards the blade 304′. Inthis way tissue may be clamped between the blade 304′ and the clamp face308. Energizing the end effector 304 may cause coagulation and/orcutting of the clamped tissue.

The various components of the surgical device 300 may be arranged in anysuitable way. FIGS. 19-20 illustrate a handle region of one embodimentof the device 300 shown in FIG. 10. According to various embodiments, aframe member 316 may couple to the handle 312 and the trigger 310. Thehandle 312 may include a slot 334 for receiving the trigger 310. Whenthe trigger 310 is positioned within the slot 334, and the frame member316 is fitted over the handle 312 and trigger 310, the bore holes 328,330 and 332 may align (FIGS. 11-12). Pin 320 may pass through bore holes328, 330 and 332 to secure the frame member 316, the handle 312 and thetrigger 310. The transducer assembly 302 and the end effector 304 may bereceived into a cavity 334 of the frame member 316. The sheath 314 maybe received into a distal end of the cavity 334. A pin 318 may be placedthrough bore holes 340, 338 and 342 to secure the sheath 314, the endeffector 304 and the frame member 316. In addition, the sheath 314 mayinclude a tongue feature 324 that may be received into a correspondinggroove feature 336 of the handle 312. (FIG. 11) FIGS. 17-18 illustrateone embodiment of a lower jaw 306 and outer sheath 314 of the surgicaldevice 300 shown in FIG. 10, including a view of the tongue feature 324of the sheath 314.

The lower jaw 306 may be coupled to the trigger 310 as well as thesheath 314, allowing the lower jaw 306 to translate relative to thesheath 314 and the end effector 304 when the trigger 310 is drawn towardthe handle 312. For example, the lower jaw 306 may define a groovefeature 326 configured to receive the tongue feature 324 of the sheath(FIGS. 17-18). A proximal end 348 of the lower jaw 306 may define one ormore bore holes 346. The bore hole(s) 346 may be aligned with a slot 344of the trigger 312, allowing pin 322 to be inserted. As illustrated inFIG. 19, the trigger 310 may pivot toward the handle 312 about pin 320.This may cause the pin 322 to slide within the slot 344, exerting aproximally directed force on the lower jaw 306 and causing the clampface 308 to translate toward the blade 304′ of the end effector 304.

In the embodiments described above, the lower jaw 306 is slidable whilethe end effector 304 remains stationary. FIG. 20A illustrates oneembodiment of a surgical device 300′ where the lower jaw is stationaryand the end effector is slidable. A frame member 316′ may couple thetransducer 302, sheath 314 and end effector 304. A trigger 310′ maycouple to a consolidated handle/lower jaw member 306′ at pivot point380, and to the frame member 316′ at pivot point 382. According tovarious embodiments, the pivot points 380 and 382 may comprise a pin andslot, as described above. In use, the clinician may pull the trigger310′ toward the proximal portion of the handle/lower jaw member 306′.This may cause the trigger 310′ to rotate about the pivot point 380 andexert a distal force on the frame member 316′, transducer 302 and endeffector 304, pushing the blade 304′ of the end effector distally towardthe clamp face 308.

FIG. 20B illustrates one embodiment of the surgical device 300′ wherethe end effector 304 is configured to rotate as it moves forward towardthe clamp face 308. The frame member 316′ may include slots 390. The endeffector 304 may include a pin 392, which may be received by the slots390. As the end effector 304 is moved distally, as described above, theorientation of the slots 392 may exert a torque on the pint 392, andconsequently the end effector 304, causing it to rotate as shown. Invarious embodiments, the pin 392 may be replaced with multiple pins (notshown). For example, one pin may be placed on a first side of the endeffector 304 and may be received by a first slot 390, while another pinmay be placed on a second side of the end effector 304 and may bereceived by a second slot 390 opposite the first.

The end effector 304 and the blade 304′ may be constructed according toany suitable solid or hollow-core configuration. FIGS. 21 illustrates adistal portion of one embodiment of the surgical device shown in FIG. 10including a blade 304′ defining a hollow lumen 350. FIG. 22 illustratesone embodiment of the blade 304′ shown in FIG. 21. According to variousembodiments, suction may be provided through the lumen 350 to aspiratetissue that is cut and coagulated by the end effector 304. FIG. 23illustrates a distal portion of one embodiment of the surgical device300 shown in FIG. 10 including a blade 304′ defining a hollow lumen 350and having two members 352 extending across the hollow lumen 350. FIG.24 illustrates one embodiment of the blade 304′ shown in FIG. 21. Themembers 352 may serve to cut tissue into portions smaller than thediameter of the lumen 350, thus lessening the risk of clogging the lumen350. Various embodiments may include more or fewer members 352 than areshown. Also, the members 352 are shown to intersect one another at aright angle, although any other suitable configuration may be used.

FIG. 25 illustrates a distal portion of one embodiment of the surgicaldevice 300 shown in FIG. 10 including a jaw member 306 defining a lumen,while FIG. 26 illustrates one embodiment of a blade 304′ for use withthe surgical device as shown in FIG. 25. The blade 304′ of the endeffector 304 may define a cavity 360. When the clamp face 308 is broughttoward the blade 304′, the cavity 360 may cover a corresponding well 356defined by the lower jaw 306. They well 356 may define an opening 354 toa lumen located within the lower jaw 306. Tissue cut and or coagulatedby the end effector 304 may be aspirated via the lumen and its opening354. FIG. 26A illustrates an additional embodiment of the blade 304′having cutting members 361 positioned within the cavity 360. In use, thecutting members may morcellate tissue, reducing the size of tissuepieces received into the opening 354 and lessening the risk that thelumen will clog. FIG. 27 illustrates a distal portion of one embodimentof the surgical device shown in FIG. 10. In the embodiment shown in FIG.27, the end effector 304 may include a blade 304′ defining a sharp edge364. The blade 304′ may cover the well 356 and lumen opening 354 asdescribed above.

FIG. 28 illustrates a distal portion of one embodiment of the surgicaldevice 300 shown in FIG. 10 including a plug feature 362 received into ahollow lumen 350 of the end effector 304. When the clamp face 308 isbrought toward the end effector 304, the plug feature 362 may bereceived into a lumen 350 defined by the end effector 304. In this way,the plug feature may help to remove any clogs or blockages presentwithin the lumen 350. According to various embodiments, the plug feature362 may have a cross sectional area smaller than that of the lumen 350.This may generally limit tissue portions removed by the device 300 tosizes smaller than the diameter of the lumen 350, reducing thelikelihood of clogs.

FIG. 28A illustrates one embodiment of the surgical device 300 includinga rotating end effector 370. The rotating end effector 370 may mount toan electric motor 372. FIG. 28B illustrates one embodiment of theelectric motor 372 mounted to the end effector 370. A rotor 376 of themotor 372 may be mounted around the end effector 370. A coil 374 of themotor 372 may, when energized, cause the rotor 376 and end effector 370to rotate clockwise or counter-clockwise. In use, the lower jaw 306 maybe translated with respect to the end effector 370, causing the clampface 308 to translate toward a blade 370′ of the rotating end effector370. According to various embodiments, the embodiment shown in FIGS. 28Aand 28B also may include a transducer (not shown in FIGS. 28A and 28B)for ultrasonically exciting the end effector 370. Accordingly, the endeffector 370 may be rotated and ultrasonically excited simultaneously.Also, FIG. 28A illustrates a clamp pad 377 positioned between the clampface 308 and the blade 370′. The clamp pad 377 may be made from anysuitable material including, for example, a polymeric material.

FIG. 28C illustrates one embodiment of the surgical device 300″ havingan angled blade 304″. The lower jaw 306 and clamp face 308″ may sliderelative to the end effector 304 and blade 304″ according to anysuitable method including, for example, the methods described above withrespect to FIGS. 10, 20A, and 20B. The blade 304″ may have a distalsurface 381 that is angled relative to the device 300″. For example, thedistal surface 381 of the blade 304″ may be angled at an angle of 45°.According to various embodiments, the clamp face 308″ may also beangled, as shown, to match the angle of the blade 304″.

FIGS. 29-36 show various embodiments of hollow core end effectors thatmay be utilized to cut and/or coagulate tissue. The end effectors maydefine a central lumen and may comprise at least one member extendedacross at least a portion of the central lumen at a distal end of theend effector. The member or members may serve to break-up bone or othertissue before it passes through the lumen, making it less likely thatthe lumen will be clogged by tissue material. According to variousembodiments, the end effectors may be utilized with any suitable manualor ultrasonic instrument. For example, the end effectors may be utilizedwith the surgical devices 10, 250 and 300 described above.

FIG. 29 illustrates one embodiment of a hollow core end effector 400comprising members 404, 406 extending across a lumen 402 defined by theend effector 400. The members 404 and 406 may comprise wires that may bebonded to the end effector 400 at various points including points 408and 410. The wires may be bonded to the end effector 400 according toany suitable method including, welding, adhesive, etc. Also, althoughthe embodiment shown in FIG. 29 includes two members 404 and 406intersecting at about the center of the lumen 402, it will beappreciated that any other suitable configuration or number of membersmay be utilized. FIG. 30 illustrates one embodiment of a hollow core endeffector 412 comprising members 414, 416 extending across a lumen 402,while FIG. 31 illustrates a cut away view of one embodiment of thehollow core end effector 412 shown in FIG. 30. In the embodiment shownin FIGS. 30-31, the members 414 and 416 may be machined into the endeffector 412 itself. Accordingly, portions of the members 414, 416 mayextend proximally into the lumen 402. FIG. 31A illustrates oneembodiment of a hollow core end effector 413 having angled members 417.The members 417 may not extend across the lumen 402. Instead, some orall of the angled members 417 may terminate in a central portion of thelumen 402.

FIG. 32 illustrates one embodiment of an end effector 418 having anon-integral blade 420. The blade 420 may include one or more members422, for example, as described above with respect to end effectors 400and 412. The blade 420 may be bonded to the remainder of the endeffector 418 according to any suitable method. For example, the surfaces424 and 426 may be threaded, allowing the blade 420 to be threaded ontothe remainder of the end effector 418. Also, the blade 420 and endeffector 418 may be coupled by press fitting, welding, brazing, adhesivebonding, etc. According to various embodiments, the non-integral blade420 and the remainder of the end effector 418 may be made from differentmaterials. For example, the end effector 418 may be made from a titaniumalloy or other material with a low resistance to ultrasonic wavetransmission. The blade 420 may be, in turn, made from material that iseasily machined, and/or holds an edge such as, for example, a steel.

FIG. 33 illustrates one embodiment of an end effector 428 having amember 430 extended across a lumen 434 and edges 432 extending beyondthe member 430. The member 430, as shown, is positioned proximally fromthe distal edge of the end effector 428. For example, the member 430 maybe recessed within the lumen 434 by a distance of up to 15 mm. FIG. 34illustrates one embodiment of an end effector 436 having an inter-lumenmember 442 positioned non-parallel to a longitudinal axis 440 of the endeffector 436. The member 442 may extend proximally into the lumen 438 atan angle that is not parallel to the axis 440. This may facilitate thecutting and removing of small portions of tissue, such as tissue portion441. FIG. 35 illustrates one embodiment of an end effector 444 having amulti-section inter-lumen member 448. Each of the sections 450, 452 ofthe inter-lumen member 448 may be positioned at different anglesrelative to the longitudinal axis 446. FIG. 36 illustrates oneembodiment of an end effector 454 having inter-lumen members 458, 460extending distally from the lumen 434. The members 458, 460 may beangled relative to the longitudinal axis 459, as described above. Themembers 458 and 460 also may extend beyond the distal edge of the otherportions of the end effector 454.

FIGS. 37-54 illustrate various embodiments of surgical devices that maybe used as an ultrasonic or unpowered device to remove tissue portions.The embodiments illustrated in FIGS. 37-54 may be useful in surgicalapplications where it is desirable to remove a core or other integralportion of bone or other tissue. The devices may generally comprise acentral instrument configured to engage tissue and an outer sheathsurrounding the central instrument. The central instrument and sheathmay be slidable relative to one another. Also, the outer sheath maycomprise a distal edge configured to clamp the tissue when the centralinstrument is slid to a position proximal from the distal edge of theouter sheath.

FIGS. 37-40 illustrate a sequence of one embodiment of a surgical device500 in use. The surgical device 500 may comprise a central instrument502 and an outer sheath 504. The central instrument 502 comprises twojaw members 506 and 508. In use, the jaw member 506 may be pivotabletoward the jaw member 508. According to various embodiments, the jawmember 508 may be ultrasonically energized, for example, as describedabove. FIG. 37 illustrates one embodiment of the surgical device 500with a portion of tissue 510 positioned between the jaw members 506,508. FIG. 38 illustrates one embodiment of the surgical device 500 shownin FIG. 37 where the central instrument 502 is grasping tissue. This mayoccur when the jaw members 506, 508 are pivoted toward one another toengage the tissue 510. In the embodiment shown in FIG. 38, the outersheath 504 has been moved distally relative to the central instrument502. FIG. 39 illustrates one embodiment of the surgical device 500 shownin FIG. 37 where the outer sheath 504 has clamped the tissue 510. Thismay occur when a distal portion of the outer sheath 504 clears thedistal edge of the central instrument 502, allowing the outer sheath504, and/or a component thereof, to clamp the tissue 510. According tovarious embodiments, a distal edge 512 of the outer sheath 504 maydefine a sharp edge to sever the tissue. Also, according to variousembodiments, outer sheath 504 may be ultrasonically activated to promotecutting and/or coagulation. Once the outer sheath 504 has clamped thetissue 510, a clinician may manipulate the device 500, causing theclamped tissue 510 to tear or break. FIG. 40 illustrates one embodimentof the surgical device 500 shown in FIG. 37 where the tissue 510 hasbeen severed.

The outer sheath 504 may exert a clamping force on the tissue 510according to various different methods. For example, the outer sheath504 may be constructed such that the distal edge portion 512 is biasedin upon itself. Accordingly, the rest state of the edge portion 512 maybe a closed or clamped position, as illustrated in FIG. 40. When thecentral instrument 502 is extended distally through the outer sheath504, it may separate the edge portion 512, for example, as illustratedin FIGS. 37-38. According to various embodiments, the distal edge 512may include multiple distal edge portions separated by one or morelongitudinal slots (not shown). This may allow the distal edge 512 toseparate. When the central instrument 502 is retracted through the outersheath 504 the edge portion 512 may contract to its closed or clampedposition, cutting or otherwise clamping the tissue 510. According tovarious embodiments, the edge portion 512 of the outer sheath 504 may beultrasonically activated to promote cutting and/or coagulation of thetissue 510.

FIGS. 41-42 illustrate one embodiment of the surgical device 500 shownin FIG. 37 where the outer sheath comprises edge members 514. The edgemembers 514 may extend distally, as shown in FIG. 41, in response to theactuation of a trigger or other component of the device (not shown).When the edge members 514 reach the distal end of the outer sheath, theycontract toward one another, as shown in FIG. 42, to sever or otherwiseclamp the tissue 510. According to various embodiments, the members 514may be ultrasonically activated.

FIGS. 43-46 illustrate one embodiment of the outer sheath 504 includingjaw members 520. The jaw members 520 may pivot toward one another aboutpivot points 524 in response to distal movement of extenders 522. Forexample, when the central instrument 502 is initially engaging tissue510, as shown in FIGS. 37-38, the extenders 522 may be retracted,leaving the jaw members 520 in an open position as shown in FIGS. 43 and45. When the outer sheath 504 is extended distally relative to thecentral instrument, the extenders 522 may be translated distally. Distaltranslation of the extenders 522 may be caused by various mechanical orautomated forces, for example, in response to a clinician activating atrigger or other component of the device (not shown). This distaltranslation may cause the jaw members 520 to pivot about pivot points524 to a closed position, as shown in FIGS. 44 and 46.

FIGS. 47-51 illustrate another sequence of one embodiment of a surgicaldevice 500 in use. The embodiment shown in FIGS. 47-51 may comprise acentral instrument 530 that includes an ultrasonic end effector defininga coring cavity 532. When the central instrument 530 is extended intotissue 510, it may cut and/or coagulate around a portion of the tissue535 corresponding to the cavity 532. FIG. 47 illustrates one embodimentof the surgical instrument 500 brought into the proximity of a mass oftissue 510. FIG. 48 illustrates one embodiment of the surgicalinstrument 500 of FIG. 47 where the central instrument 530 is extendedinto the tissue 510. Ultrasonic energy may be provided to the centralinstrument 530, allowing it to cut into the tissue 510. FIG. 49illustrates one embodiment of the surgical instrument 500 of FIG. 47where the central instrument 530 has been retracted from the tissue 510,leaving a core section 535 that has been partially severed from thetissue 510. FIG. 50 illustrates one embodiment of the surgicalinstrument 500 of FIG. 47 where the outer sheath 504 has been extendedinto the tissue 510. The outer sheath 504 may either sever the coresection 535, or clamp it, allowing the clinician to tear or otherwiseloosen the core section 535. FIG. 51 illustrates one embodiment of thesurgical instrument 500 of FIG. 47 where the outer sheath 504 has beenretracted from the tissue 510, removing the core section 535. Accordingto various embodiments, the device 500 may omit the central instrument502. For example, the outer sheath 504 may be ultrasonically energizedto cut a portion of the tissue 510 in a manner similar to that of thecentral instrument 530. The outer sheath 504 may then clamp the tissue510 for severing or tearing, for example, as described above.

The surgical device 500 may be operated by a clinician from a handleportion (not shown) that may include one or more triggers for actuatingthe central instrument 502 and the outer sheath 504. For example, thecentral instrument 502 may be actuated by any suitable manual orautomatic means including, for example, a mechanical design similar tothat described above with respect to the blade 180′ and clamp arm 190.The outer sheath 504 may similarly be extended and actuated by anysuitable manual or automatic means. For example, the outer sheath 504may be extended distally in response to the actuation of a trigger in amanner similar to the way that the reciprocal actuating member 170 isextended distally in response to actuation of the operating lever 222described above. According to various embodiments, the centralinstrument 502 and the outer sheath 504 may be actuated by a single pullof a trigger. For example, a single trigger pull may both actuate thecentral instrument 502 and also subsequently extend and actuate theouter sheath 504.

FIGS. 52-55 illustrate force-feedback surgical devices, according tovarious embodiments, configured to apply ultrasonic energy to tissue ata variable power level and/or end effector amplitude. The level of poweror end effector amplitude provided to the devices may be determined, forexample, based on the force applied to a trigger, and/or the position ortravel of the trigger. It will be appreciated that force feedbacksurgical devices, such as the embodiments shown in FIGS. 52-55, may giveclinicians an increased level of control over the ultrasonic powerdelivered by the devices, facilitating precise operations.

FIG. 52 illustrates a block diagram of one embodiment of a forcefeedback surgical device 600. The device 600 may include an ultrasonicend effector 602, which may be activated when a clinician operates atrigger 610. When the trigger 610 is actuated, a force sensor 612 maygenerate a signal indicating the amount of force being applied to thetrigger 610. In addition to, or instead of force sensor 612, the device600 may include a position sensor 613, which may generate a signalindicating the position of the trigger 610 (e.g., how far the triggerhas been depressed or otherwise actuated). A control circuit 608 mayreceive the signals from the sensors 612 and/or 613. The control circuit608 may include any suitable analog or digital circuit components. Thecontrol circuit 608 also may communicate with the generator 606 and/orthe transducer 604 to modulate the power delivered to the end effector602 and/or the generator level or blade amplitude of the end effector602 based on the force applied to the trigger 610 and/or the position ofthe trigger 610. For example, as more force is applied to the trigger610, more power and/or a higher blade amplitude may be delivered to theend effector 602. According to various embodiments, the force sensor 612may be replaced by a multi-position switch (not shown). Each position ofthe switch may correspond to a different level of power to be deliveredto the end effector 602.

According to various embodiments, the end effector 602 may include aclamping mechanism, for example, such as that described above withrespect to FIG. 4. When the trigger 610 is initially actuated, clampingmechanism may close, clamping tissue between a clamp arm and the endeffector 602. As the force applied to the trigger increases (e.g., assensed by force sensor 612) the control circuit 608 may increase thepower delivered to the end effector 602 by the transducer 604 and/or thegenerator level or blade amplitude brought about in the end effector602. In one embodiment, trigger position, as sensed by position sensor613, may be used by the control circuit 608 to set the power and/oramplitude of the end effector 602. For example, as the trigger is movedfurther towards a fully actuated position, the power and/or amplitude ofthe end effector 602 may be increased.

According to various embodiments, the surgical device 600 also mayinclude one or more feedback devices for indicating the amount of powerdelivered to the end effector 602. For example, a speaker 614 may emit asignal indicative of the end effector power. According to variousembodiments, the speaker 614 may emit a series of pulse sounds, wherethe frequency of the sounds indicates power. In addition to, or insteadof the speaker 614, the device may include a visual display 616. Thevisual display 616 may indicate end effector power according to anysuitable method. For example, the visual display 616 may include aseries of light emitting diodes (LEDs), where end effector power isindicated by the number of illuminated LEDs. The speaker 614 and/orvisual display 616 may be driven by the control circuit 608. Accordingto various embodiments, the device 600 may include a ratcheting device(not shown) connected to the trigger 610. The ratcheting device maygenerate an audible sound as more force is applied to the trigger 610,providing an indirect indication of end effector power.

The device 600 may include other features that may enhance safety. Forexample, the control circuit 608 may be configured to prevent power frombeing delivered to the end effector 602 in excess of a predeterminedthreshold. Also, the control circuit 608 may implement a delay betweenthe time when a change in end effector power is indicated (e.g., byspeaker 614 or display 616), and the time when the change in endeffector power is delivered. In this way, a clinician may have amplewarning that the level of ultrasonic power that is to be delivered tothe end effector 602 is about to change.

Force-feedback ultrasonic devices, such as the device 600, may bephysically implemented in any suitable form. For example, FIG. 53illustrates one embodiment of a force-feedback surgical device 620. Thedevice 620 may comprise an ultrasonic end effector 622 excitable by atransducer 632. The transducer 632 may be in communication with agenerator (not shown) via a wire 636. A clamp arm 624 may be pivotabletowards the end effector 622 when a clinician pulls a trigger 628towards a handle 626, similar to the clamp arm 190 and blade 180′described above. A sensor 630 positioned on the trigger 628 may measurethe force applied to the trigger 628 by the clinician and/or theposition of the trigger 628. It will be appreciated that the sensor 630may be alternatively placed at other locations within the device 620including, for example, at trigger pivot point 634 or between the endeffector 622 and clamp arm 624. A control circuit (not shown) may bepositioned at any suitable location on or in the device 620 including,for example, within the handle 626 or trigger 628, the ultrasonic driveunit 50 or the generator 30.

FIG. 54-55 illustrate one embodiment of another force-feedback surgicaldevice 640, which may be configured as an ultrasonic rongeur-typedevice. The device 640 may include a pair of handles 642, 644 that whensqueezed towards one another about pivot point 646 may cause a pair ofdistally positioned jaw members 648, 650 to pivot towards one another toengage tissue by clamping or severing. One or both of the jaw members648, 650 may include an ultrasonically active end effector. For example,FIG. 54 illustrates an ultrasonic end effector 652 positioned on jawmember 650 and driven by transducer 656. The transducer 656 may be incommunication with a generator (not shown) via a wire 657. A clamp pad654 may be positioned opposite the end effector 652. The transducer 656may be positioned between the handles 642, 644, as shown, or at anyother suitable position. For example, the transducer 656 may bepositioned within one of the handles 642, 644. Force sensors 658, 660may be positioned on the handles 642, 644 as shown, or may be positionedat various other locations within the device 640 including, for example,at the pivot point 646. Likewise, the control circuit (not shown) may bepositioned at any suitable location on or in the device 640.

FIG. 56 illustrates one embodiment of another force feedback surgicaldevice 700 comprising a hand-piece adapter 708. The device 700 may alsocomprise a transducer 704 configured to drive an end effector 702, forexample, as described herein. The hand-piece adapter 708 may compriseone or more switches 706 for operating the transducer 704 and endeffector 702. For example, actuating one or more of the switches 706 maycause the device 700 to activate. The switches 706 may correspond to thetrigger 610 described with respect to FIG. 52. One or more sensors (notshown in FIG. 56) may be provided to sense the travel of the switches706 and/or the amount of force applied to the switches 706 by theclinician. A control circuit (not shown in FIG. 56) may modulate thedevice power and/or end effector amplitude based on the output of theone or more sensors as described herein.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device may be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular elements, and subsequent reassembly. In particular, thedevice may be disassembled, and any number of particular elements orcomponents of the device may be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular components,the device may be reassembled for subsequent use either at areconditioning facility, or by a surgical team immediately prior to asurgical procedure. Those skilled in the art will appreciate thatreconditioning of a device may utilize a variety of techniques fordisassembly, cleaning/replacement, and reassembly. Use of suchtechniques, and the resulting reconditioned device, are all within thescope of the present application.

Preferably, the various embodiments described herein will be processedbefore surgery. First, a new or used instrument is obtained and ifnecessary cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK® bag. The container and instrumentare then placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation kills bacteria on the instrument and in the container. Thesterilized instrument can then be stored in the sterile container. Thesealed container keeps the instrument sterile until it is opened in themedical facility.

It is preferred that the device is sterilized prior to surgery. This canbe done by any number of ways known to those skilled in the artincluding beta or gamma radiation, ethylene oxide, steam.

Although various embodiments have been described herein, manymodifications and variations to those embodiments may be implemented.For example, different types of end effectors may be employed. Also,where materials are disclosed for certain components, other materialsmay be used. The foregoing description and following claims are intendedto cover all such modification and variations.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

1-49. (canceled)
 50. A surgical device comprising: a transducerconfigured to energize an end effector, wherein the end effector iscoupled to the transducer; a trigger actuatable to cause the endeffector to be energized; a sensor positioned to sense a force exertedon the trigger; and a control circuit in communication with the sensor,wherein the control circuit is configured to increase power delivered tothe end effector by the transducer in response to an increase of theforce exerted on the trigger.
 51. The surgical device of claim 50,wherein the transducer is configured to be inactive until the forceexerted on the trigger reaches a predetermined threshold.
 52. Thesurgical device of claim 50, further comprising a feedback device incommunication with the control circuit, wherein the feedback device isconfigured to indicate power delivered to the end effector.
 53. Thesurgical device of claim 52, wherein the control circuit is configuredto delay a predetermined amount of time between indicating a change inpower delivered to the end effector and increasing the power deliveredto the end effector by the transducer.
 54. The surgical device of claim52, further comprising a light source, wherein the light sourceindicates an amount of power delivered to the end effector by thetransducer.
 55. The surgical device of claim 52, further comprising aspeaker configured to generate an audible signal indicating an amount ofpower delivered to the end effector by the transducer.
 56. The surgicaldevice of claim 52, wherein the device is configured to provide anaudible signal as the force exerted on the trigger increases.
 57. Thesurgical device of claim 50, wherein the control circuit is configurednot to exceed a predetermined power delivered to the end effector by thetransducer.
 58. The surgical device of claim 50, further comprising aclamp arm pivotable toward the end effector about a pivot point.
 59. Thesurgical device of claim 58, wherein the trigger is actuatable to pivotthe clamp arm about the pivot point.
 60. A method for processing asurgical instrument for surgery, comprising: obtaining the surgicaldevice of claim 50; sterilizing the surgical device; and storing thesurgical device in a sterile container.
 61. A surgical devicecomprising: a transducer configured to energize an end effector, whereinthe end effector is coupled to the transducer; a trigger actuatable tocause the end effector to be energized; a sensor positioned to sense aposition of the trigger; and a control circuit in communication with thesensor, wherein the control circuit is configured to increase powerdelivered to the end effector by the transducer in response to a changein the position of the trigger.